"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. ROXICET (oxycodone and acetaminophen ) is given orally.
ROXICET (oxycodone and acetaminophen ) Tablets
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 tablets.)
ROXICET (oxycodone and acetaminophen ) Oral Solution
The usual adult dosage is 5 mL (one teaspoonful) every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 teaspoonfuls or 60 mL.)
Cessation of Therapy
In patients treated with ROXICET (oxycodone and acetaminophen ) for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.
ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets, USP (Oxycodone
Hydrochloride 5 mg and Acetaminophen 325 mg)
White, round, scored tablets
(Identified 54 543)
NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper.
NDC 0054-4650-25: Bottles of 100 tablets.
NDC 0054-4650-29: Bottles of 500 tablets.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight light-resistant container, as defined in the USP/NF.
ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution
(Oxycodone Hydrochloride 5 mg and Acetiminophen 325 mg Oral Solution per 5 mL)
Clear, dark red solution
NDC 0054-8648-16: Unit dose Patient Cups™ filled to deliver 5 mL (Oxycodone Hydrochloride 5 mg, Acetaminophen 325 mg), ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper.
NDC 0054-3686-63: Bottles of 500 mL.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight light-resistant container, as defined in the USP/NF.
DEA Order Form Required., Revised May, 2007. Roxane Laboratories, Inc. Columbus, Ohio 43216
Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Roxicet Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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